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NCT05700669 · ClinicalTrials.gov registry record · Phase 1

Study to Assess Safety and Efficacy of AsiDNA in Combination with Olaparib in Participants with Recurrent Solid Tumors

A Phase 1 study, sponsored by Valerio Therapeutics.

Completed
Registry status
Phase 1
Development phase
3
Enrollment target

NCT05700669: Completed Phase 1 study, sponsored by Valerio Therapeutics.

NCT05700669 is a Phase 1 study that has completed, run by Valerio Therapeutics. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05700669, a Phase 1 study, has completed, sponsored by Valerio Therapeutics.

COMPLETED
Registry status
Phase 1
Development phase
3 participants
Enrollment target

Study Summary

This is a phase 1b/2 open-label, multicenter, basket study to determine the safety, anti-tumor activity, tolerability, and pharmacokinetics /pharmacodynamics of AsiDNA in combination with olaparib in participants with recurrent epithelial ovarian cancer, breast cancer and metastatic castration-resistant prostate cancer who have progressed on previous Poly (ADP-ribose) polymerase (PARP) inhibitor therapy. The study will be conducted in two phases. The Phase 1b dose escalation study designed to establish the safety, tolerability, pharmacologically active doses/ maximum tolerated dose and/or recommended phase 2 dose of AsiDNA in combination with olaparib.

Primary Outcome

• Dose-limiting toxicities (DLTs) as determined by adverse events (AEs) according to Common Terminology Criteria for Adverse Events (CTCAE 5.0)

Interventions

  • DRUG Olaparib
  • DRUG AsiDNA

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2023-02-20
Est. Completion 2023-10-31
Phase Phase 1
Valerio Therapeutics

13 total trials

What the finished NCT05700669 record still lists

NCT05700669 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 2 interventions - of which Olaparib is the first listed.

NCT05700669 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05700669 about?

NCT05700669 is a clinical study titled "Study to Assess Safety and Efficacy of AsiDNA in Combination with Olaparib in Participants with Recurrent Solid Tumors". This is a phase 1b/2 open-label, multicenter, basket study to determine the safety, anti-tumor activity, tolerability, and pharmacokinetics /pharmacodynamics of AsiDNA in combination with olaparib in participants with recurrent epithelial ovarian cancer, breast cancer and metastatic castration-resis...

What is the current status of trial NCT05700669?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2023-02-20. Estimated completion is 2023-10-31.

What interventions are being tested in trial NCT05700669?

The interventions under investigation include: Olaparib (DRUG), AsiDNA (DRUG).

Who is sponsoring clinical trial NCT05700669?

This trial is sponsored by Valerio Therapeutics, which has 13 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05700669's enrollment target sits among peer trials

3 1999th of 2000 higher than 1 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05700669, the US trial registry maintained by the National Library of Medicine. NCT05700669 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.